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Medication double-checking procedures in clinical practice – a survey of oncology nurses’ experiences

Journal: BMJ Open

Manuscript ID bmjopen-2016-011394

Article Type: Research

Date Submitted by the Author: 04-Feb-2016

Complete List of Authors: Schwappach, David; Patient Safety Foundation; University of Bern Pfeiffer, Yvonne; Patient Safety Foundation Taxis, Katja; Pharmacotherapy and Pharmaceutical Care, University of Groningen

<b>Primary Subject Heading</b>:

Health services research

Secondary Subject Heading: Health services research, Oncology, Nursing

Keywords:

Risk management < HEALTH SERVICES ADMINISTRATION &

MANAGEMENT, Organisation of health services < HEALTH SERVICES ADMINISTRATION & MANAGEMENT, Quality in health care < HEALTH SERVICES ADMINISTRATION & MANAGEMENT, ONCOLOGY, patient safety

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Short title: Nurses’ Experiences with double-checking

Original Research

Medication double-checking procedures in clinical practice – a survey of oncology nurses’

experiences

D. L. B. Schwappach*1,2, Yvonne Pfeiffer1, Katja Taxis3

*Corresponding author: Prof. Dr. David Schwappach, MPH

1 Swiss Patient Safety Foundation. Asylstr. 77. 8032 Zuerich, Switzerland. Tel. 0041 43

2441480; Fax 0041 43 2441481. Email: [email protected]

2 Institute of Social and Preventive Medicine (ISPM). University of Bern.

3 Department of Pharmacy, Unit of Pharmacotherapy and Pharmaceutical Care, University of

Groningen, Groningen, The Netherlands.

Key words: Patient Safety; Medication Errors; Oncology; Double-Check; Survey

Word count: 3822

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ABSTRACT

Background: Double-checking is thought of as an essential feature to prevent medication

errors, but little is known about actual practice in oncology.

Objective: To study the practice of double-checking procedures and to explore nurses’

experiences and views towards double-checking in chemotherapy administration.

Methods: This was a cross-sectional survey of qualified nurses working in oncology

departments of three hospitals. Nurses were asked to rate five different scenarios of double-

checking procedures regarding frequency of use in practice and appropriateness to prevent

medication errors.

Results: Overall, 274 nurses (70% response rate) participated in the survey. The method of

jointly double-checking (“Read-read back”) was most commonly used (69% of respondents)

and rated as very appropriate to prevent medication errors. Jointly checking medication was

seen as the essential characteristic of double-checking – more frequently than “carrying out

checks independently” (54% vs 24% of respondents). Regression analysis confirmed that the

scenario of jointly double-checking was found more appropriate to prevent medication errors

than independent checking (p<0.001) and revealed a preference towards checks that are

currently implemented at responders’ workplace. Overall, 78% of nurses found the frequency

of double-checking in their department appropriate. Double-checking several medications

without a break was reported as most frequent violation of procedures (at least several times

a month reported by 48% respondents). Being interrupted in one’s own current activity for

supporting a double-check was reported to occur frequently (39% reported 1-5 interruptions

per day, 20% >5).

Conclusion: Nurses working in oncology used joint double-checking frequently, preferred this

method over others, and rated it as appropriate to prevent medication errors despite its lack

of independence. The high frequency of reported interruptions during and caused by double-

checks is of concern.

STRENGTHS AND LIMITATIONS OF THIS STUDY

• This is the first investigation into double-checking procedures and common violations

in cancer care.

• We provide evidence that the value of double-checking procedures as perceived by

nurses is attributed to the joint action rather than the independence of checks and

thus does not match current recommendations claiming that checks need to be

carried out independently to increase safety.

• The survey response rate is satisfactory and the sample includes nurses from three

large hospitals. However, results may be subject to bias due to the self-reported

nature of the data.

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INTRODUCTION

Medication errors pose a serious threat to cancer patients [1-5]. Walsh et al. reported that

among adult cancer patient visits, 7.1% of medications were associated with a medication

error with more than half of all errors occurring during administration [6]. Although not all

medication errors are harmful, consequences can be serious or disastrous, especially in

cancer patients. Strategies that have been recommended to improve patient safety in

oncology include electronic prescribing, standardization of processes and order forms,

shifting medication-related tasks to clinical pharmacists, and use of checklists for safe

administration of drugs [7-11]. Double-checking of medication is the safety intervention most

frequently called for, especially to prevent administration errors. Double-checking (DC) can

be defined as a procedure that requires two qualified health professionals, usually nurses,

checking the medication before administration to the patient. The DC is a redundant function

based on the subjective theory that human errors can be minimized by other individual’s

compensatory behavior [12]. The strategy is borrowed from system engineering where

redundancy is used to achieve safety and reliability in technical systems. Redundancy as a

design strategy for healthcare systems has been discussed by Tamuz and Harrison in the

context of high-reliability theory and normal accident theory [13]. Despite the proliferation of

the procedure and its ad-hoc plausibility, there is a paucity of research into the effectiveness

of double-checking to either support or refute this practice [14]. In this context, it is important

to note that double-checking medication administrations is a time consuming and thus

resource intensive process [15-17].

There is widespread support for DC, but most recommendations and guidelines lack details

on what constitutes a DC and how it should be performed. In practice, various forms of DC

procedures are implemented including a single person conducting the same check twice; a

second person verifying the check of the first professional (do-and-show check); a single

person checking against some form of computerized support (e.g., calculations performed by

an infusion pump); two professionals checking independently from each other, and

sequentially or together (e.g., read-read back). Due to such variability in DC processes, it is

not surprising that there are reports about confusion and misconceptions among healthcare

professionals [18]. In a recent qualitative study in Canada, the DC was inconsistently

conceptualized among healthcare professionals with a variety of ambiguous but “taken as

understood” meanings attached to it [19]. Nurses at many departments today perform

countless single and double drug verifications, often under inadequate working conditions

(e.g., insufficient light, space, noise) and without any compensation for the time needed to

perform these checks. Often these checks are done superficially [20] and “true

independence” of checks – the central feature for successful error detection – is hard to

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achieve in practice. Non-independent checks are prone to confirmation bias and their value

is thus uncertain. Violations of DC procedures are frequent, probably due to work-load and

lack of standardization [20,21]. Furthermore, double-checking itself can impact safety

negatively in causing a considerable number of additional interruptions to the workflow.

Finally, diffusion of responsibility can lead to a false sense of safety through reliance on the

following check [22] and thus increase risks. In qualitative studies, nurses indicated that the

DC reduced the perceived responsibility of individuals because they trust in the second

checking person to find potential mistakes – an effect, which is often called “social loafing”

[18,23].

In oncology, double-checking is frequently recommended and claimed as “state of the art”

procedure [24,25]. The Swiss nursing standards on chemotherapy administration state that,

depending on the institutional policy, a double-check of the drug and the dose should be

conducted during preparation and administration [26]. However, despite its wide diffusion,

very little is known about DC practices in cancer care in particular. This study addresses this

gap. We explored practice patterns (types, frequencies and independence of checks

performed) and oncology nurses’ experiences and views towards the DC in chemotherapy

administration in a cross-sectional survey. We assessed what constitutes a ‘good DC’ for

cancer nurses, how frequently procedures are violated, which barriers nurses perceive in

conducting DC in practice, and whether they would prefer an expansion or a reduction of DC

procedures. As clinical processes and working conditions often differ between wards and

ambulatory infusion units and this may also impact on how DCs are performed and

perceived, we explored differences between these models of care provision. We assessed

which specific DC routines are implemented and what the experiences with them are. In

particular, we were interested in nurses’ judgments about the suitability of the various

different DC procedures in discovering medication errors and the factors affecting their

evaluations. We assumed that nurses have clear judgments on the value of different DC

routines based on their prior experiences.

METHODS

survey

The survey was developed by the investigators based on the literature, consultations with

experts and clinical staff. Direct observation of double checks on sites was conducted to gain

an understanding of the different forms of DC procedures implemented in clinical practice at

the participating units. The survey consisted of two main sections: In the first section

(reported herein), we used scenarios describing DC procedures implemented in clinical

practice and asked responders to rate these scenarios regarding various aspects. This

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allowed us to assess practice patterns, experiences with different DC procedures and

clinicians’ judgments of the effectiveness of DC procedures in discovering medication errors.

We used the scenarios of different DC procedures to obtain detailed evaluations and to avoid

the loosely and inconsistently defined “umbrella concept” of double checking. In this section,

we also asked some general items about DC, e.g., regarding unit policy or perception of

essential elements of DC. The second survey section (not reported herein) assessed norms

and beliefs in DC effectiveness for medication safety.

In the field observations, we identified five different core DC procedures. For each of them,

we developed a brief description and an illustration of the main steps (scenarios A-E, see

figures 1 and 2). Each participant responded to all scenarios and was asked the same set of

questions for each scenario:

1) item 1: How appropriate this type of DC is to prevent medication errors

(“appropriateness rating”; 7-point Likert from “very appropriate” to “not appropriate at

all”);

2) item 2: whether this type of DC is being performed at their unit (yes routinely/only in

exceptions/no/ don’t know); if yes:

3) item 3: How many of such DCs they personally conduct on an average

working day, including cytostatics, potassium, antiemetics (none/1-5 /6-10

/more than 10);

4) item 4: how frequently they detect errors, discrepancies, or inconsistencies

during a DC of this type (daily or several times daily/weekly or several times

weekly/monthly or several times monthly/few times per year/never);

5) item 5: whether they would eliminate this type of DC, in case they were free

to decide for their unit (yes/no keep as is/perform only in exceptions);

6) item 6, only for scenarios C,D,E, which describe counting and calculating:

whether the second nurse already knows the results of her colleague when

she repeats the procedure (e.g., whether she can see the ticket with the

number of tablets or the flow rate, etc.) (yes/no).

Participants were then asked to complete a number of generalized items: They were asked

to indicate the existence of guidelines for DC at their unit; essential elements of a good DC;

number of DCs at their unit; the frequency of violations of DC procedures; frequency of

interruptions caused by DC and conditions interfering with performing a good DC; practice

and preferences towards the DC of premedications; and recent experience of severe

medication errors. Finally, respondents completed a few socio-demographic and work-

related items. Six experts from nursing, oncology, clinical pharmacy, and hospital risk

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management gave feedback on a survey draft. The survey was pretested for clarity and

wording in a sample of n=39 HCW from two hospitals not participating in the main study.

Only minor adjustments were made.

sample

Three hospitals participated with their oncology departments (two university hospitals, one

large regional hospital). From each hospital the oncology wards and ambulatory units took

part. All qualified nurses (i.e., nursing staff authorized to prepare and administer

chemotherapy) working on the participating units received the survey together with a pre-

paid envelope and a chocolate bar. Return of the survey was regarded informed consent.

The study was deemed exempt by the Cantonal ethics committee (KEK ZH Nr. 34-2015).

analysis

Survey responses were descriptively analyzed. Chi-square tests were conducted to identify

group differences between wards and ambulatory infusion units. In order to test for

differences in appropriateness ratings between DC scenarios, Anova was used. Multiple

regression analysis was conducted to determine which factors predict the appropriateness

rating (dependent variable, item 1 listed above). The unit of analysis was the judgment

provided in response to each scenario, and not the individual respondent. Type of DC

procedure evaluated (scenarios A-E), current implementation of this DC procedure at the

unit, perceived essential element of a good DC, and personal and work-related

characteristics were included as predictors (independent variables). We used cluster robust

standard errors to relax the assumption of independence of observations within individuals.

All tests were two-sided and a p-value <0.05 was considered significant.

RESULTS

Of the 389 distributed surveys, 274 were completed and returned (response rate=70%).

Sample details are provided in table 1. The majority of responders were experienced nurses

working on wards for at least 25 hours per week in direct patient care. 80% of the nurses

reported that there were internal guidelines explaining which checks were required for which

medications and that they knew them well. 11% knew that such guidelines existed but did not

know their content well. The remainder was not aware of guidelines for their unit. Overall, 68

responders (25%) reported that one or more serious medication errors had taken place in

their unit during the past 12 months. Of those, the majority (68%) believed that the last

serious error that happened could have been prevented with a thorough DC.

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practice patterns and experiences with DC procedures

Table 2 reports practice patterns and experiences with the different DC scenarios.“Read-

read back“ of orders and infusion bag labels (scenario A) was the most widely implemented

DC procedure. A repetitive single check of order and infusion bag (scenario B) was least

common. Within each type of DC scenario, the largest fraction of responders was involved in

1 to 5 checks per average working day. Nurses working on ambulatory units were involved in

significant higher frequencies of DCs. Summarized across the different DC procedures, 48%

of all frequency ratings provided by ambulatory nurses indicate performance of > 5 checks

per day vs. 15% of these ratings reported by nurses on ward (p<0.001). The reported

frequency with which DC procedures detected errors and inconsistencies varied

considerably. Approximately a fifth of nurses practicing procedure B (repetitive single check)

and C (repetitive single check of order, calculations, and drugs for preparation) reported that

these checks detected inconsistencies at least several times a week. Contrary, the more

widely implemented DC procedures were reported to detect inconsistencies with much lower

frequency. Only between 37% (scenario C) and 51% (scenario E) of participants reported

that commonly the second nurse did not know the results of her preceding colleague when

she repeated a counting or calculating procedure (truly independent check). Across all

presented DC procedures, the majority of responders would not eliminate the procedure from

their routines (range: 73%-94%).

characteristics of the DC and violations

Participants were clearly discordant on what constitutes the essential characteristic of a good

DC: 'two persons check the medication together' was selected as main feature by 54%; 'two

persons make the same checks successively' was selected by 22% of responders and only

24% answered that 'one person independently repeats a process (e.g., counting) without

knowing the results of her preceding colleague' was the crucial characteristic of a good DC.

There were no significant differences in views on the main feature of a good DC between

nurses working on wards or at ambulatory units. Nurses reported different types of violations

of medication safety rules related to the DC with varying levels of frequency (table 3):

Performing the DC for several patients in series – without a break and without completing the

drug administration before starting the DC for the next patient – was the most commonly

reported deviation from safe DC rules. 36% of responders reported any of the three types of

violations to happen at least several times per week at their unit (ambulatory infusion unit:

46%; ward=32%, p=0.074).

number of DCs at unit

When asked to consider the number of DCs at their unit, most surveyed nurses regarded the

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scheduled number of DCs at their unit as good and appropriate (78%). 17% favored

additional DCs. Only a small minority said there should be fewer DCs (5%). A preference

towards additional DCs was significantly more frequent among responders working on wards

compared to ambulatory infusion units (21% vs. 2%, p=0.005). Half of the respondents (49%)

reported that premedications were not double-checked at all at their unit (19% routinely and

28% occasionally). Responders were nearly equally split in their preferences for or against

the DC of premedications: 55% said they would favor and 45% would opt against a routine

DC of all premedications, were they free to decide for their unit. Those who already routinely

performed DCs on premedications were much more likely to support this procedure (90%) as

compared to those that checked them only occasionally or not at all (47%, OR=10.43,

p<0.001).

interruptions and barriers for DC performance

Many nurses reported that they were frequently interrupted in their own tasks to support a

colleague doing a DC: 39% self-reported 1-5 interruptions of their current activity per day; a

substantial fraction (20%) experienced more than 5 interruptions per day. Nurses working at

ambulatory infusion units self-reported significantly more interruptions than nurses working

on wards (40% vs. 16% reporting more than five interruptions per day, p=0.001). Nearly all

respondents (96%) reported at least one factor which frequently interferes with performing a

good DC (multiple answers possible): 78% felt disturbed by hurry and hectic at the unit, 78%

by interruptions and distractions, 58% by noise and poor illumination in the medication room,

53% by problems to find a colleague for the DC, 29% by overcrowded rooms and 25% by

their own fatigue.

appropriateness of DC procedures and its predictors

Responders evaluated the appropriateness of each of the five DC procedures for preventing

medication errors, irrespective of whether they perform this type of check in their daily

routines. The differences in the appropriateness ratings between the DC procedures were

considerable (Anova F=76.6, p<0.0001). The ratings were highest for scenarios A

(mean=6.0, CI 5.8-6.1) and E (mean=6.0, CI 5.8- 6.1), followed by D (mean 5.5, CI 5.3-5.7),

C (mean=4.9, CI 4.8-5.2), and B (mean=3.9, CI 3.7- 4.2). Results of the regression analysis

confirm that the appropriateness of the five different DC procedures was judged differently,

even after adjusting for other variables (table 4). DC procedures B and C were perceived as

being significantly less useful in preventing medication errors. DC procedures which were

implemented at the responder’s work environment and thus currently personally experienced

were systematically attached higher appropriateness ratings, even after adjusting for the type

of check and other variables. The difference between the categories “not practiced” and

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“occasionally practiced” explained, on average, a one-point difference on the response scale.

In other words, responders who perceived the redundancy of single checks as the main

characteristic of a high-quality DC provided slightly higher appropriateness ratings,

irrespective of the particular DC procedure under evaluation. This indicated a preference

towards medication checks, irrespective of their specific nature. Finally, fewer working hours

in direct patient care and female gender were the only personal and work-related variables

affecting the perceived benefit of the DC procedures for preventing medication errors.

Working on ward or at the ambulatory units did not affect appropriateness ratings.

DISCUSSION

To the authors‘ knowledge this is the first analysis of nurses‘ experiences with and views

towards the double-checking of medication in cancer care. We surveyed experienced

oncology nurses from three large hospitals including wards and ambulatory infusion units.

The response rate was satisfactory.

Our study confirms qualitative research regarding the variability in interpretations and ideas

of what constitutes a DC [18,19]. Only a quarter regarded the independence of checks as the

essential feature of the DC whereas twice as much selected “doing the checks together”. In

scenarios which allow configuration of an independent check (scenarios C-E) only 37-51% of

responders reported that the routine is currently implemented in order to achieve

independence (i.e., not knowing the results of the co-worker). This points to a structural and

prevalent misunderstanding of the rationale behind double checking procedures. In contrast

to technical and engineered systems one basic prerequisite of the redundancy principle is

violated in social systems – independence between redundant “units” [27]: Inanimate objects

are unaware of each other while human subjects are aware that their coworkers will conduct

a redundant check. While independence within the specific check itself can be more or less

simulated (e.g., by not sharing information as recommended in DC guidelines)[28], even

simply knowing that a second check will be conducted may negatively affect motivation and

result in the tendency to make less effort. The violation of independence can result in greater

diffusion of responsibility and thus decreased system safety [12]. This has been confirmed in

qualitative studies, in which nurses indicated that the DC would reduce the perceived

responsibility of individuals because others would pick up potential mistakes [18,23].

Furthermore, the identified misconception of the independence principle in combination with

the result that many nurses felt disturbed by environmental factors means that while doing

their checks together, nurses are subject to the same environmental impacts, such as

insufficient light or noise or interruptions. Thus, a specific noise may distract both nurses just

in the same way and thus an error could be made despite the redundant check.

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Consequently, we advocate to critically discuss what true independence in double checking

means and how it can be achieved in clinical practice. We would also like to raise awareness

about potential hazards that may be connected to DC. Analyses of incidents revealed how

many collaborative cross-checks failed and did not prevent severe incidents [29]. Oncology

nurses in our survey judged the read-read-back procedure, a routine which relies on the

presence and literally “dialogue” of two nurses, as most appropriate. These professionals are

persistently confronted with administering high-risk drugs to vulnerable patients and the

genuine function of DC here may indeed be to share responsibility for safe drug

administration.

Our results also highlight the interplay between the DC and interruptions in workflow: Nurses

reported frequent interruptions caused by the DC, in particular at the ambulatory infusion

units, and often felt disturbed by interruptions during a DC. Given the evidence that

interruptions in medication-related tasks are strongly associated with errors, this is alarming

[30,31]. Based on direct observation of medication administration, Trbovich et al. reported

that nurses in ambulatory infusion units were interrupted 22% of their time and frequently

interrupted during safety-critical stages [32]. Prakash et al. recently investigated the effects of

interruptions during chemotherapy verification and administration on the frequency of errors

[33]. In this study, nurses made significantly more errors in verification of medication volumes

in syringes and infusion pumps when interrupted. Taking these studies into account, our

results indicate that without reorganizing DC routines in clinical practice, the procedure may

in fact increase the risk for error.

Nurses in our study clearly found typical DC procedures to be of different value with the joint

“read-read back” check involving two nurses being rated the most appropriate. The variance

in ratings confirms that participants sensitively responded to the scenario descriptions and

adjusted their judgment accordingly. However, the results also emphasize a “bias towards

the known” with regard to currently practiced DC procedures. Whether a certain check was

implemented at the unit was a significant independent predictor for a high appropriateness

rating which co-exists with differentiated judgments about the appropriateness of different

procedures. This status quo bias is also expressed in various other survey items: For

example, the vast majority of responders indicated that they would not eliminate or change

the frequency of specific checks and regarded the extent of checks at their unit as “just right”.

This preference against change may explain the virtual “inviolability” of the DC

notwithstanding the increasing evidence questioning the effectiveness of currently

implemented DC procedures. A strong reluctance to de-implementation was also reported in

an Australian study in which nurses held strong views against single checking before the

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change in practice [34]. The strong support showed in the high positive appropriateness

ratings for all checking procedures and the result that more than half of the respondents

would also prefer to double check premedications may be connected to the personal

experiences reported by the nurses: for all procedures presented, there were between 45%

and 25% of the answers indicating that at least several errors per month had been detected

using this method. Thus, in their everyday work life, nurses commonly make the experience

that inconsistencies are detected with double checking. Contrary, inconsistencies not found

during checking and the extent of errors which remain invisible but could be found with other

checking procedures are not personally experienced. Thus, every “hit” sends a positive

feedback and reinforces and confirms the positive attitude towards the DC.

LIMITATIONS

Our study has some limitations: First, it relies on self-reported practices and experiences and

is as such subject to various biases. For example, nurses may under- or overestimate the

true prevalence of DC rule violations or the frequency with which DC detects inconsistencies.

Second, to overcome the poor conceptualization of the umbrella term “double-check” we

prepared descriptions of core sub-processes based on observations in clinical practice. This

has the advantage that participants shared a basic common understanding when answering

survey questions. On the other hand, specific aspects or steps of DC procedures in the

specific units may not have been taken into account in the scenarios or may have lured

respondents into to a false sense of detail, although we have no indication of this (e.g., in the

free text response fields in the survey).

CONCLUSIONS

Generally, the survey showed that double checking is a procedure well-supported by nurses

working in oncology which, in their experience, frequently helps to detect errors. They used

joint double-checking frequently, preferred this method over others and rated it appropriate to

prevent medication errors. These findings show that clinicians’ perspectives are not matching

current recommendations claiming that checks need to be carried out independently to

increase safety. Thus, knowledge about the importance of independence in double checking

needs to be transferred more actively into clinical practice, so that healthcare professionals

implementing and using double check procedures can adopt their procedures accordingly.

The high frequency of reported interruptions during and caused by double-checks is of great

concern. Existing ideas to reduce interruptions during checking such as quiet zones need to

be developed and tested in future research.

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ACKNOWLEDGMENTS

We thank all nurses who participated in the survey.

CONTRIBUTORSHIP STATEMENT

DS, YP and KT contributed to design of the study and the Survey instrument. DS analyzed

the data. YP and KT contributed to interpretation of data. DS wrote the draft, YP and KT

provided important intellectual Content. All authors approved the manuscript.

COMPETING INTERESTS

There are no competing interests.

FUNDING

This work was supported by a research grant from Krebsforschung Schweiz [Cancer

Research Switzerland, KFS-3496-08-2014] and an unrestricted research grant by the

Hanela-Stiftung.

DATA SHARING STATEMENT

No additional data are available.

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6. Walsh KE, Dodd KS, Seetharaman K, et al. Medication errors among adults and

children with cancer in the outpatient setting. J Clin Oncol 2009;27:891-6.

7. Womer RB, Tracy E, Soo-Hoo W, et al. Multidisciplinary Systems Approach to

Chemotherapy Safety: Rebuilding Processes and Holding the Gains. J Clin Oncol

2002;20:4705-12.

8. Voeffray M, Pannatier A, Stupp R, et al. Effect of computerisation on the quality and

safety of chemotherapy prescription. Qual Saf Health Care 2006;15:418-21.

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Multidisciplinary Approach to Create Templated Order Sets. J Pediatr Oncol Nurs

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10. Goldspiel BR, DeChristoforo R, Daniels CE. A continuous-improvement approach for

reducing the number of chemotherapy-related medication errors. Am J Health Syst

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11. David BA, Rodriguez A, Marks SW. Risk Reduction and Systematic Error Management:

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Keyes MA, Grady ML, editors. Advances in Patient Safety: New Directions and

Alternative Approaches.Rockville: Agency for Healthcare Research and Quality; 2008.

12. Schöbel M, Manzey D. Subjective theories of organizing and learning from events.

Safety Science 2011;49:47-54.

13. Tamuz M, Harrison MI. Improving Patient Safety in Hospitals: Contributions of High-

Reliability Theory and Normal Accident Theory. Health Serv Res 2006;41:1654-76.

14. Alsulami Z, Conroy S, Choonara I. Double checking the administration of medicines:

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what is the evidence? A systematic review. Arch Dis Child 2012;97:833-7.

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17. White RE, Trbovich PL, Easty AC, et al. Checking it twice: an evaluation of checklists

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process and procedure of double-checking medications. J Clin Nurs 2010;19:728-35.

19. Hewitt T, Chreim S, Forster A. Double checking: a second look. J Eval Clin Pract

2015;doi: 10.1111/jep.12468.

20. Conroy S, Appleby K, Bostock D, et al. Medication errors in a children's hospital.

Paediatric and Perinatal Drug Therapy 2007;8:18-25.

21. Alsulami Z, Choonara I, Conroy S. Paediatric nurses' adherence to the double-checking

process during medication administration in a children's hospital: an observational

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study of adverse events. Qual Health Care 2000;9:120-6.

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Eval Clin Pract 2008;14:513-9.

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25. Jacobson J, Polovich M, McNiff K, et al. American Society of Clinical

Oncology/Oncology Nursing Society Chemotherapy Administration Safety Standards.

Oncol Nurs Forum 2009;36:651-8.

26. Onkologiepflege Schweiz. Nationale Standards: Verabreichung der Chemotherapie.

Leitfaden für die Praxis. Bern: Onkologiepflege Schweiz; 2008.

27. Sagan SD. The problem of redundancy problem: Why more nuclear security forces

may produce less nuclear security. Risk Anal 2004;24:935-46.

28. Institute for Safe Medication Practices (ISMP). Independent double checks:

undervalued and misused. ISMP Medication Safety Alert 2013;18.

29. Patterson ES, Woods DD, Cook RI, et al. Collaborative cross-checking to enhance

resilience. Cognition, Technology & Work 2007;9:155-62.

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30. Rivera-Rodriguez AJ, Karsh BT. Interruptions and distractions in healthcare: review and

reappraisal. Qual Saf Health Care 2010;19:304-12.

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Risk and Severity of Medication Administration Errors. Arch Intern Med 2010;170:683-

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Medications. J Nurs Adm 2010;40:211-8.

33. Prakash V, Koczmara C, Savage P, et al. Mitigating errors caused by interruptions

during medication verification and administration: interventions in a simulated

ambulatory chemotherapy setting. BMJ Quality & Safety 2014;23:884-92.

34. O'Connell B, Crawford S, Tull A, et al. Nurses' attitudes to single checking medications:

Before and after its use. International Journal of Nursing Practice 2007;13:377-82.

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TABLES

Table 1: Characteristics of survey responders (n=274)

Characteristic Responders

n %

Female Gender 240 91

Age, mean (SD) years 37 (10)

18-25 years 31 12

26-40 years 149 56

41-55 years 67 25

56-65 years 17 6

Qualification*

Qualified nurse 205 76

Oncology nursing expert 42 16

Head nurse 17 6

Other 4 1

Primary place of work

Ward / Oncology day care unit 220 82

Ambulatory infusion unit 48 18

Weekly hours in direct patient care

<10 hours / week 14 5

10-25 hours / week 60 23

25-40 hours / week 123 47

> 40 hours / week 67 25

Experience with barcode scanning (e.g., blood products) 123 46

Preparation of cytostatics at unit 82 31

Years of practice in oncology

< 1 year 25 10

1-5 years 89 36

5-10 years 55 22

> 10 years 79 32

* Categories may not sum up to 100% due to missing values

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Table 2: Practice patterns and experiences with different DC procedures (scenarios) (for item

wordings, see methods)

DC procedure, n (% within DC procedure)

A B C D E

Type of DC performed at unit (item 2)

routinely 185 (69%) 57 (21%) 87 (33%) 117 (45%) 175 (66%)

exceptionally 40 (15%) 34 (13%) 43 (16%) 64 (24%) 8 (3%)

Not performed 45 (17%) 175 (66%) 131 (50%) 81 (31%) 81 (31%)

Number of DCs responder is doing on an average day* (item 3)

none 16 (7%) 21 (23%) 20 (15%) 21 (12%) 14 (8%)

1 – 5 158 (70%) 40 (44%) 81 (62%) 133 (74%) 138 (76%)

6 – 10 36 (16%) 14 (16%) 13 (10%) 14 (8%) 15 (8%)

> 10 15 (7%) 15 (17%) 17 (13%) 11 (6%) 14 (8%)

DC performed “truly” independent* (item 6)

yes - - - - 47 (37%) 81 (46%) 89 (51%)

Frequency of detection of errors / inconsistencies during DC* (item 4)

Never / rarely+ 167 (75%) 49 (55%) 72 (56%) 114 (64%) 130 (72%)

Several per month 39 (17%) 23 (26%) 31 (24%) 48 (27%) 37 (20%)

Several per week / day+ 18 (8%) 17 (19%) 26 (20%) 17 (9%) 14 (8%)

Preference to eliminate this type of DC* (item 5)

Eliminate completely 7 (3%) 2 (2%) 2 (2%) 5 (3%) 1 (1%)

Do it only in exceptional cases 23 (10%) 22 (25%) 26 (20%) 30 (17%) 10 (6%)

Keep as is 194 (87%) 65 (73%) 100 (78%) 144 (80%) 167 (94%)

*Only participants who reported that the type of DC is being performed at their unit (routinely /

occasionally) answered these items

+ Distinct categories merged for analysis

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Table 3: Frequency of self-reported deviations from DC safety rules

Deviation from DC safety rules several times

daily

several times

weekly

several times

monthly

less frequently

or never

How frequently is a scheduled DC

done only superficially, is not

completed or not conducted at all?

2

(0.7%)

16

(6%)

25

(9%)

239

(84%)

How frequently does a patient get

her medication from staff who was

not involved in the DC of this

medication?

6

(2%)

27

(10%)

44

(17%)

188

(71%)

How frequently are the medications

of several patients double-checked

in series without break?

29

(11%)

42

(16%)

54

(21%)

135

(52%)

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Table 4: Results of regression analysis with DC appropriateness rating as outcome; model

with cluster robust standard errors

Variable 95% CI P value

DC type ( to reference “A”)

B -1.252 -1.501,-1.003 <0.001

C -0.483 -0.693,-0.273 <0.001

D -0.155 -0.349,0.039 0.116

E 0.154 -0.013,0.322 0.071

DC performed at own unit (to reference “yes, regularly”)

occasionally -0.555 -0.772,-0.337 <0.001

no -1.632 -1.875,-1.389 <0.001

Essential characteristic of DC (to reference “'two nurses check together”)

Repeated single check 0.284 -0.001,0.568 0.050

Two independently 0.129 -0.120,0.379 0.308

Age, years 0.000 -0.011,0.012 0.959

Female gender 0.676 0.199,1.154 0.006

Weekly working hours in direct patient care (to reference “< 25 hours”)

25-40 hours -0.350 -0.613,-0.087 0.009

>40 hours -0.305 -0.635,0.025 0.070

Experienced with barcode

scanning

-0.061 -0.278,0.157 0.583

Head nurse -0.270 -0.686,0.146 0.202

Working on ward (vs.

ambulatory infusion unit)

-0.118 -0.390,0.153 0.391

Serious medication error in

the past 12 months

-0.208 -0.461,0.046 0.108

Constant 6.199 5.152,7.247 <0.001

Number of observations 1190

Number of individuals 248

R-squared 0.41

overall model p <0.001

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FIGURES LEGENDS

Figure 1: DC scenarios and descriptions provided in the survey

Figure 2: Illustration of DC procedure A provided in the survey

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150x137mm (300 x 300 DPI)

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2003x468mm (72 x 72 DPI)

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Medication double-checking procedures in clinical practice – a cross-sectional survey of oncology nurses’ experiences

Journal: BMJ Open

Manuscript ID bmjopen-2016-011394.R1


Date Submitted by the Author: 01-Apr-2016





Keywords:




BMJ Open on A


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Original Research

Medication double-checking procedures in clinical practice – a cross-sectional survey of

oncology nurses’ experiences









Word count: 4631

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ABSTRACT

Background: Double-checking is widely recommended as an essential method to prevent

medication errors. However, prior research has shown that the concept of double-checking is

not clearly defined, and that little is known about actual practice in oncology, e.g., what kind

of checking procedures are applied.

Objective: To study the practice of different double-checking procedures in chemotherapy

administration and to explore nurses’ experiences e.g., how often they actually find errors

using a certain procedure. General evaluations regarding double-checking, e.g., frequency of

interruptions during and caused by a check, or what is regarded as its essential feature were

assessed.

Methods: In a cross-sectional survey, qualified nurses working in oncology departments of

three hospitals were asked to rate five different scenarios of double-checking procedures

regarding dimensions such as frequency of use in practice and appropriateness to prevent

medication errors; they were also asked general questions about double-checking.

Results: Overall, 274 nurses (70% response rate) participated in the survey. The procedure

of jointly double-checking (“Read-read back”) was most commonly used (69% of

respondents) and rated as very appropriate to prevent medication errors. Jointly checking

medication was seen as the essential characteristic of double-checking – more frequently

than “carrying out checks independently” (54% vs 24). Most nurses (78%) found the

frequency of double-checking in their department appropriate. Being interrupted in one’s own

current activity for supporting a double-check was reported to occur frequently. Regression

analysis revealed a strong preference towards checks that are currently implemented at the

responders’ workplace.

Conclusion: Double-checking is well-regarded as a procedure to help prevent errors by

oncology nurses, with jointly checking being used most frequently. Our results showed that

the notion of independent checking needs to be transferred more actively into clinical

practice. The high frequency of reported interruptions during and caused by double-checks is

of concern.

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in cancer care.







nature of the data.

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INTRODUCTION

Medication errors pose a serious threat to cancer patients (1-5). Walsh et al. reported that


error with more than half of all errors occurring during administration (6). Although not all





administration of drugs (7-11). Double-checking of medication is the safety intervention

frequently called for, especially to prevent administration errors. The Institute for Safe

Medication Practices (ISMP) recommends the implementation of the double-check, but

judiciously, and in a standardized process (12). The ISMP also points to the importance of

independence of checking procedures where the first professional does not communicate the

results to expect to the second professional. The UK National Patient Safety Agency

recommends health care organizations to “use double-checking systems such as an

independent check by another practitioner, and dose checking software in ‘Smart’ infusion

pumps and syringe drivers” (13). Double-checking (DC) can be defined as a procedure that

requires two qualified health professionals, usually nurses, checking the medication before

administration to the patient. DC is a redundant function based on the subjective theory that

human errors can be minimized by other individual’s compensatory behavior (14). The

strategy is borrowed from system engineering where redundancy is used to achieve safety

and reliability in technical systems. In broad terms, redundancy means that a system

component (e.g., mass storage) is duplicated and serves as a back-up in case of failure.

Redundancy as a design strategy for healthcare systems has been discussed by Tamuz and

Harrison in the context of high-reliability theory and normal accident theory (15). Despite the

proliferation of the procedure and its ad-hoc plausibility, there is a paucity of research into the

effectiveness of double-checking to either support or refute this practice (16). In this context,

it is important to note that double-checking medication administrations is a time consuming

and thus resource intensive process (17-19).


on what constitutes a double-check and how it should be performed. In practice, various

forms of DC procedures are implemented including, for example, a single person conducting

the same check twice; a second person verifying the check of the first professional (do-and-

show check); a single person checking against some form of computerized support (e.g.,

calculations performed by an infusion pump); two professionals checking independently from

each other, and sequentially or together (e.g., read-read back). Due to such variability in DC

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processes, it is not surprising that there are reports about confusion and misconceptions

among healthcare professionals (20;21). In a recent qualitative study in Canada, DC was

inconsistently conceptualized among healthcare professionals with a variety of ambiguous

but “taken as understood” meanings attached to it (21). Nurses at many departments today

perform countless single and double drug verifications, often under inadequate working

conditions (e.g., insufficient light, space, noise) and without any compensation for the time

needed to perform these checks. Often these checks are done superficially (22) and “true




lack of standardization (22;23). Furthermore, DC itself can negatively impact safety by

causing a considerable number of additional interruptions in workflow. Finally, diffusion of

responsibility can lead to a false sense of safety through reliance on the following check (24)

and thus increase risk. In qualitative studies, nurses indicated that DC reduced the perceived

responsibility of individuals because they trust in the second checking person to find potential

mistakes – an effect, which is often called “social loafing” (20;25).

In oncology, DC is frequently recommended and claimed as a “state of the art” procedure

(26;27). The American Society of Clinical Oncology (ASCO) and the Oncology Nursing

Society (ONS) standards for the administration of chemotherapy require that before

chemotherapy administration, at least two practitioners a) verify patient identification using at

least two identifiers; b) confirm with the patient the planned treatment, drug route, and

symptom management; c) verify the accuracy of drug name, dose, volume, rate of and route

of administration, expiration dates/times and appearance and physical integrity of the drugs;

d) sign to indicate verification was done [16]. The Swiss nursing standards on chemotherapy

administration are not binding and state that, depending on the institutional policy, a double-

check of the drug and the dose should be conducted during preparation and administration

(28). There is, however, neither a definition or an explanation of a robust checking procedure

given in the document nor recommendations on how DC should exactly be performed

proposed.

Despite its wide diffusion, very little is known about DC practices in cancer care. This study

addresses this gap using a cross-sectional survey among oncology nurses. The main aim of

our study was to assess practice patterns (types, frequencies and independence of checks

performed) and oncology nurses’ experiences with the double-check in chemotherapy

administration. A major aim of our study was to assess which specific DC routines are

implemented and what the experiences with them are. In particular, we were interested in

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nurses’ judgments about the suitability of the various different DC procedures in discovering

medication errors and the factors affecting their evaluations. We assumed that nurses have

clear judgments on the value of different DC routines based on their prior experiences and

their professional expertise. We examined what constitutes a ‘good double-check’ for cancer

nurses, how frequently procedures are violated, which barriers nurses perceive in conducting

DC in practice, and whether they would prefer an expansion or a reduction of DC

procedures. Understanding nurses’ assessments of suitability of DC procedures and the

determinants affecting them is crucial for implementing any changes to current DC practices

and for being able to support the development a consistent conceptualization of DC in the

future. A specific question we addressed were the differences in DC practices between

inpatient and outpatient care. Clinical processes and working conditions (e.g., patient flow

and throughput, staffing, etc.) often differ considerably between wards and ambulatory

infusion units and we assumed that this may also impact how double-checks are performed

and perceived. Knowledge about these differences would be useful for designing DC

procedures and policies that are adapted to a specific setting and context.

METHODS

Survey


experts and clinical staff, and initial field observations. The main challenge in developing the

survey was the inconsistent, vague and variable concepts held by nurse clinicians and the

various procedures implemented in practice. It became obvious that simply asking details

about “the double-check” would result in non-interpretable data due to non-standardized use

of the term. Therefore, we assessed in initial field observations which checking procedures

are performed in practice. One author visited all participating units and observed DC

practices to gain an understanding of the different forms of DC procedures implemented.

Based on the observations, we developed a) a set of scenarios describing certain

procedures and b) survey questions that were asked for every kind of scenario in order to be

able to compare the scenarios. In informal conversations during and after observation,

nurses were asked about the procedures in a non-judgmental manner until the core steps,

their sequence, the actions and interactions between staff were clear for each scenario. The

initial observations also gave insights into common rules embedded in checking procedures

(which are not necessarily written down anywhere). For example, medications should be

administered by a nurse involved in the DC and not by a third person, and double-checks

should not be done in series for the medications of several patients. Finally, the field

observations were also useful to collect information about the environmental conditions

under which DC is performed (e.g., rooms, light, noise).

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Six experts from nursing, oncology, clinical pharmacy, and hospital risk management gave

feedback on a survey draft. The survey was pretested for clarity and wording in a sample of

n=39 HCW from two hospitals not participating in the main study. Only minor adjustments

were made.

The survey consisted of two main sections: In the first section (reported herein), we used

scenarios describing DC procedures implemented in clinical practice and asked responders

to rate these scenarios regarding various aspects. This allowed us to assess practice

patterns, experiences with different DC procedures and clinicians’ judgments of the

effectiveness of DC procedures in discovering medication errors. We used these scenarios

of different DC procedures to obtain detailed evaluations and to avoid the loosely and

inconsistently defined “umbrella concept” of DC. In this section, we also asked some general

items related to DC, e.g., regarding unit policy or perception of essential elements of DC. The

second survey part (not reported herein) assessed norms and beliefs in DC effectiveness for

medication safety.

In the field observations, we identified five different core DC procedures implemented in

practice. For each of them, we developed a brief description and an illustration of the main

steps (scenarios A-E, see figures 1 and 2). Each participant responded to all scenarios and

was asked the same set of questions for each scenario:



all”);



3) item 3: How many of such double-checks they personally conduct on an

average working day, including cytostatics, potassium, antiemetics (none/1-5

/6-10 /more than 10);


during a double-check of this type (daily or several times daily/weekly or

several times weekly/monthly or several times monthly/few times per

year/never);






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to indicate the existence of guidelines for DC at their unit; essential elements of a good

double-check; number of double-checks at their unit; the frequency of violations of DC

procedures (see table 3 for details); frequency of interruptions caused by DC and conditions

interfering with performing a good double-check; practice and preferences towards the DC of

premedications (drugs given prior to chemotherapy to prevent side effects of treatment, e.g.,

antiemetic drugs and steroids); and recent experience of severe medication errors. Finally,

respondents completed a few socio-demographic and work-related items.

Sample





paid envelope and a chocolate bar. Return of the survey was considered as implied informed

consent. The study was deemed exempt by the Cantonal ethics committee (KEK ZH Nr. 34-

2015) on the basis of the Swiss legislation (Human Research Act, HRA). Our study does not

involve interventions, no health-related data or biological material are being analyzed, the

data were completely anonymized and approached individuals could easily refuse

participation by not returning the survey.

Analysis

Survey responses were descriptively analyzed. Due to item-level missing data, the sample

size varies slightly per item. Chi-square tests were conducted to identify group differences

between wards and ambulatory infusion units. In order to test for differences in

appropriateness ratings between DC scenarios, ANOVA was used.

Logistic regression analysis was conducted to determine which factors explain the

appropriateness rating (dependent variable, item 1 listed above). The unit of analysis was the

judgment provided in response to each scenario, and not the individual respondent. The

dependent variable (appropriateness rating) was dichotomized with values 1-4=not

appropriate and values 5-7=appropriate. Type of DC procedure evaluated (scenarios A-E),

current implementation of this DC procedure at the unit, and perceived essential element of a

good double-check were included as predictors (independent variables). The former of these

two variables together detangle judgments on the appropriateness of the distinct DC

procedures and nurses’ current practices at their workplace. Personal and work-related

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characteristics were included to adjust the appropriateness ratings. We used cluster robust

standard errors to relax the assumption of independence of observations within individuals.

All tests were two-sided and a p-value <0.05 was considered significant.

RESULTS



working on wards for at least 25 hours per week in direct patient care. The majority of nurses

(80%) reported that there were internal guidelines explaining which checks were required for

which medications and that they knew them well. Knowing that such guidelines existed but

not knowing their contents well was reported by 11%. The remainder was not aware of

guidelines for their unit. Overall, 68 responders (25%) reported that one or more serious

medication errors had taken place in their unit during the past 12 months. Of those, the

majority (68%) believed that the last serious error could have been prevented with a

thorough double-check.

Practice patterns and experiences with DC procedures

Table 2 reports practice patterns and experiences with the different DC scenarios. “Read-





significant higher frequencies of double-checks. Summarized across the different DC

procedures, 48% of all frequency ratings provided by ambulatory nurses indicate

performance of > 5 checks per day vs. 15% of these ratings reported by nurses on ward

(p<0.001). The reported frequency with which DC procedures detected errors and

inconsistencies varied considerably. Approximately a fifth of nurses practicing procedure B

(repetitive single check) and C (repetitive single check of order, calculations, and drugs for

preparation) reported that these checks detected inconsistencies at least several times a

week. Contrary, the more widely implemented DC procedures were reported to detect

inconsistencies with much lower frequency. Only between 37% (scenario C) and 51%

(scenario E) of participants reported that commonly the second nurse did not know the

results of her preceding colleague when she repeated a counting or calculating procedure

(truly independent check). Across all presented DC procedures, the majority of responders

would not eliminate the procedure from their routines (range: 73%-94%).

Characteristics of the double-check and violations

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double-check: 'two persons check the medication together' was selected as main feature by

54%; 'two persons make the same checks successively' was selected by 22% of responders

and 24% answered that 'one person independently repeats a process (e.g., counting) without

knowing the results of her preceding colleague' was the crucial characteristic of a good

double-check.

There were no significant differences in evaluations of the main feature of a good double-

check between nurses working on wards or at ambulatory units. Nurses reported different

types of violations of medication safety rules related to DC with varying levels of frequency

(table 3): Performing the double-check for medications of several patients in series – without

a break and without completing the drug administration before starting the double-check for

the next patient – was the most commonly reported deviation from safe DC rules. Of

responders, 36% reported any of the three types of violations to happen at least several

times per week at their unit (ambulatory infusion unit: 46%; ward=32%, p=0.074).

Number of double-checks at unit

When asked to consider the number of double-checks at their unit, most surveyed nurses

regarded the scheduled number of double-checks in their unit as good and appropriate

(78%). Additional double-checks were favored by 17% . Only a small minority said there

should be fewer double-checks (5%). A preference towards additional double-checks was

significantly more frequent among responders working on wards compared to ambulatory

infusion units (21% vs. 2%, p=0.005). Half of the respondents (49%) reported that

premedications were not double-checked at all at their unit (19% routinely and 28%

occasionally). Responders were nearly equally split in their preferences for or against the DC

of premedications: 55% said they would favor and 45% would opt against a routine DC of all

premedications, were they free to decide for their unit. Those who already routinely

performed double-checks on premedications were much more likely to support this

procedure (90%) as compared to those that checked them only occasionally or not at all

(47%, OR=10.43, p<0.001).

Interruptions and barriers for DC performance


colleague doing a double-check: 1-5 interruptions of their current activity per day were

reported by 39% ; a substantial fraction (20%) experienced more than 5 interruptions per

day. Nurses working at ambulatory infusion units self-reported significantly more interruptions

than nurses working on wards (40% vs. 16% reporting more than five interruptions per day,

p=0.001). Nearly all respondents (96%) reported at least one factor which frequently

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interferes with performing good DC (multiple answers possible): 78% felt disturbed by hurry

and hectic at the unit, 78% by interruptions and distractions, 58% by noise and poor

illumination in the medication room, 53% by problems to find a colleague for DC, 29% by

overcrowded rooms and 25% by their own fatigue.

Appropriateness of DC procedures and its predictors



routines. The differences in the appropriateness ratings between DC procedures were

considerable (ANOVA F=76.6, p<0.0001). The ratings were highest for scenarios A


C (mean=4.9, CI 4.8-5.2), and B (mean=3.9, CI 3.7- 4.2). Results of the logistic regression

analysis confirm that the appropriateness of the five different DC procedures was judged

differently, even after adjusting for other variables (table 4). DC procedures B and C were

perceived as being significantly less useful in preventing medication errors compared to

procedures A and E. DC procedures which were implemented at the responder’s work

environment and thus currently personally experienced were systematically much more likely

to be judged appropriate, even after adjusting for the type of check and other variables:

Procedures nurses were currently using at their unit were more than 17-times more likely to

be judged appropriate. The difference between the categories “not practiced” and

“occasionally practiced” explained, on average, a one-point difference on the response scale.

Finally, female gender was the only personal and work-related variable affecting the

perceived benefit of DC procedures for preventing medication errors. Working on ward or at

the ambulatory units did not affect appropriateness ratings.

DISCUSSION

To the authors‘ knowledge this is the first analysis of nurses‘ experiences with and

evaluations of different procedures of double-checking of medication in cancer care. We

surveyed experienced oncology nurses from three large hospitals including wards and

ambulatory infusion units. The response rate was satisfactory.

In relation to our main aim, nurses in our study clearly found typical DC procedures to be of

different value with the joint “read-read back” check involving two nurses being rated the

most appropriate. The variance in ratings confirms that participants sensitively responded to

the scenario descriptions and adjusted their judgment accordingly. However, the results also

emphasize a “bias towards the known” with regard to currently practiced DC procedures.

Whether a certain check was implemented at the unit was a significant independent predictor

for a high appropriateness rating which co-exists with differentiated judgments about the

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appropriateness of different procedures. This status quo bias is also expressed in various

other survey items: For example, the vast majority of responders indicated that they would

not eliminate or change the frequency of specific checks and regarded the extent of checks

at their unit as “just right”. This preference against change may explain the virtual

“inviolability” of the double-check notwithstanding the increasing evidence questioning the

effectiveness of currently implemented DC procedures. A strong reluctance to de-

implementation was also reported in an Australian study in which nurses held strong views

against single checking before the change in practice (29). The strong support expressed in

the high positive appropriateness ratings of all checking procedures and the result that more

than half of the respondents would also prefer to double-check premedications may be

connected to the personal experiences reported by the nurses: Depending on the DC

scenario presented, between 45% and 25% of participants indicated that at least several

errors per month had been detected using this method. Thus, in their everyday work life,

nurses commonly make the experience that inconsistencies are detected with double-

checking. Contrary, inconsistencies not found during checking and the extent of errors which

remain invisible but could be found with other checking procedures are not personally

experienced. Thus, every “hit” sends a positive feedback and reinforces and confirms the

positive attitude towards DC.


of what constitutes a double-check, the importance of independence of checks and how it

can be achieved (20;21). Only a quarter regarded the independence of checks as the

essential feature of DC whereas twice as much selected “doing the checks together”. In




prevalent misunderstanding of the rationale behind double-checking procedures. One basic

prerequisite of the redundancy principle to be successful is the independence between

redundant “units” (30). In technical systems this requirement is usually satisfied because

inanimate objects (e.g., computers) which serve as backup for other inanimate objects are

unaware of each other. Their performance is unaffected by the presence or absence of the

redundant unit. In contrast, this principle is typically violated in social systems. Human

subjects are aware that their coworkers will conduct redundant checks. Independence within

the specific check itself can be more or less simulated (e.g., by not sharing information as

recommended in DC guidelines)(12). Yet, even simply knowing that a second check will be

conducted may negatively affect motivation and result in the tendency to make less effort.

The violation of independence can result in greater diffusion of responsibility and thus

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decreased system safety (14). This has been confirmed in qualitative studies, in which

nurses indicated that DC would reduce the perceived responsibility of individuals because

others would pick up potential mistakes (20;25). Furthermore, the identified misconception of

the independence principle and its importance in combination with the finding that many

nurses felt disturbed by environmental factors means that while doing their checks together,

nurses are subject to the same environmental impacts, such as insufficient light or noise or

interruptions. Thus, a specific noise may distract both nurses just in the same way and thus

an error could be made despite the redundant check. Consequently, we advocate to critically

discuss what true independence in double-checking means and how it can be achieved in

clinical practice. Our results also support the proposition to define what is meant by a double-

check more precisely (21). We would also like to raise awareness about potential hazards

that may be connected to DC. Analyses of incidents revealed how many collaborative cross-

checks failed and did not prevent severe incidents (31). Oncology nurses in our survey

judged the read-read-back procedure, a routine which relies on the presence and literally

“dialogue” of two nurses, as most appropriate. These professionals are persistently

confronted with administering high-risk drugs to vulnerable patients and the genuine function

of DC here may indeed be to share responsibility for safe drug administration. A considerable

fraction of nurses (11%) in our study reported that they did not know the contents of

medication administration guidelines at their unit well, and nearly 10% were unaware

whether such guidelines existed. This finding is per se concerning and confirms that even

local medical guidelines and safety standards are often not well disseminated and known in

practice. It may also suggest that the guidelines in place are not perceived as being usable

or helpful for practice. For example, the local guidelines of the participating units we

consulted mentioned DC, but did not provide any details on how checks should be done.

Taken together, nurses may receive confirmation and safeguarding during chemotherapy

verification from doing checks together and sharing responsibility rather than from complying

with (vague) guidelines.

Our results also highlight the interplay between DC and interruptions in workflow: Nurses

reported frequent interruptions caused by DC, in particular at the ambulatory infusion units,

and often felt disturbed by interruptions during DC. Given the evidence that interruptions in

medication-related tasks are strongly associated with errors, this is alarming (32;33). Based

on direct observation of medication administration, Trbovich et al. reported that nurses in

ambulatory infusion units were interrupted 22% of their time and frequently interrupted during

safety-critical stages (34). Prakash et al. recently investigated the effects of interruptions

during chemotherapy verification and administration on the frequency of errors (35). In this

study, nurses made significantly more errors in verification of medication volumes in syringes

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and infusion pumps when interrupted. Taking these studies into account, our results indicate

that without reorganizing DC routines in clinical practice, the procedure may in fact increase

the risk for error.

LIMITATIONS











CONCLUSIONS

Generally, the survey showed that DC is a procedure well-supported by nurses working in

oncology which, in their experience, frequently helps to detect errors. They used joint DC

frequently, preferred this method over others and rated it appropriate to prevent medication

errors. These findings show that clinicians’ perspectives are not matching current

recommendations claiming that checks need to be carried out independently to increase

safety. Thus, knowledge about the importance of independence in DC needs to be

transferred more actively into clinical practice, so that healthcare professionals implementing

and using DC procedures can adopt their procedures accordingly.The high frequency of

reported interruptions during and caused by DC is of great concern. Existing ideas to reduce

interruptions during checking such as quiet zones need to be developed and tested in future

research.

ACKNOWLEDGMENTS

We thank all nurses who participated in the survey. The support of the clinical experts in

providing feedback to the survey and especially of Anna Götz (nursing expert) in survey

design and field testing is highly appreciated.


DS, YP and KT contributed to design of the study and the survey instrument. DS analyzed


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provided important intellectual content. All authors approved the manuscript.

COMPETING INTERESTS


FUNDING



Hanela-Stiftung.



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(4) Watts RG, Parsons K. Chemotherapy medication errors in a pediatric cancer treatment center: Prospective characterization of error types and frequency and development of a quality improvement initiative to lower the error rate. Pediatr Blood Cancer 2013 Aug 1;60(8):1320-4.

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(6) Walsh KE, Dodd KS, Seetharaman K, Roblin DW, Herrinton LJ, Von Worley A, et al. Medication errors among adults and children with cancer in the outpatient setting. J Clin Oncol 2009;27:891-6.

(7) Womer RB, Tracy E, Soo-Hoo W, Bickert B, DiTaranto S, Barnsteiner JH. Multidisciplinary Systems Approach to Chemotherapy Safety: Rebuilding Processes and Holding the Gains. J Clin Oncol 2002 Dec 15;20(24):4705-12.

(8) Voeffray M, Pannatier A, Stupp R, Fucina N, Leyvraz S, Wasserfallen JB. Effect of computerisation on the quality and safety of chemotherapy prescription. Qual Saf Health Care 2006 Dec 1;15(6):418-21.

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(11) David BA, Rodriguez A, Marks SW. Risk Reduction and Systematic Error Management: Standardization of the Pediatric Chemotherapy Process. In: Henriksen K, Battles JB, Keyes MA, Grady ML, editors. Advances in Patient Safety: New Directions and Alternative Approaches.Rockville: Agency for Healthcare Research and Quality; 2008.

(12) Institute for Safe Medication Practices (ISMP). Independent double checks: undervalued and misused. ISMP Medication Safety Alert 18[12]. 2013.

(13) National Patient Safety Agency. Promoting safer use of injectable medicines. Patient Safety Alert 20. 2007.

(14) Schöbel M, Manzey D. Subjective theories of organizing and learning from events. Safety Science 2011 Jan;49(1):47-54.

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(15) Tamuz M, Harrison MI. Improving Patient Safety in Hospitals: Contributions of High-Reliability Theory and Normal Accident Theory. Health Serv Res 2006 Aug 1;41(4p2):1654-76.

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(29) O'Connell B, Crawford S, Tull A, Gaskin CJ. Nurses' attitudes to single checking medications: Before and after its use. Int J Nurs Pract 2007 Dec 1;13(6):377-82.

(30) Sagan SD. The problem of redundancy problem: Why more nuclear security forces may produce less nuclear security. Risk Anal 2004;24(4):935-46.

(31) Patterson ES, Woods DD, Cook RI, Render ML. Collaborative cross-checking to

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enhance resilience. Cognition, Technology & Work 2007;9(3):155-62.

(32) Rivera-Rodriguez AJ, Karsh BT. Interruptions and distractions in healthcare: review and reappraisal. Qual Saf Health Care 2010 Aug 1;19(4):304-12.

(33) Westbrook JI, Woods A, Rob MI, Dunsmuir WTM, Day RO. Association of Interruptions With an Increased Risk and Severity of Medication Administration Errors. Arch Intern Med 2010 Apr 26;170(8):683-90.

(34) Trbovich P, Prakash V, Stewart J, Trip K, Savage P. Interruptions During the Delivery of High-Risk Medications. J Nurs Adm 2010;40(5):211-8.

(35) Prakash V, Koczmara C, Savage P, Trip K, Stewart J, McCurdie T, et al. Mitigating errors caused by interruptions during medication verification and administration: interventions in a simulated ambulatory chemotherapy setting. BMJ Quality & Safety 2014 Jun 6;23(11):884-92.

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TABLES



n %



18-25 years 31 12

26-40 years 149 56

41-55 years 67 25

56-65 years 17 6

Qualification*



Head nurse 17 6

Other 4 1






10-25 hours / week 60 23

25-40 hours / week 123 47

> 40 hours / week 67 25




< 1 year 25 10

1-5 years 89 36

5-10 years 55 22

> 10 years 79 32


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Table 2: Practice patterns and experiences with different DC procedures (scenarios)

(for item wordings, see methods)


A B C D E


routinely 185 (69%) 57 (21%) 87 (33%) 117 (45%) 175 (66%)

exceptionally 40 (15%) 34 (13%) 43 (16%) 64 (24%) 8 (3%)

Not performed 45 (17%) 175 (66%) 131 (50%) 81 (31%) 81 (31%)

Number of double-checks responder is doing on an average day* (item 3)

none 16 (7%) 21 (23%) 20 (15%) 21 (12%) 14 (8%)

1 – 5 158 (70%) 40 (44%) 81 (62%) 133 (74%) 138 (76%)

6 – 10 36 (16%) 14 (16%) 13 (10%) 14 (8%) 15 (8%)

> 10 15 (7%) 15 (17%) 17 (13%) 11 (6%) 14 (8%)

DC performed “truly” independently* (item 6)

yes - - - - 47 (37%) 81 (46%) 89 (51%)


Never / rarely+ 167 (75%) 49 (55%) 72 (56%) 114 (64%) 130 (72%)






Keep as is 194 (87%) 65 (73%) 100 (78%) 144 (80%) 167 (94%)




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daily

several times

weekly

several times

monthly

less frequently

or never

How frequently is a scheduled

double-echeck done only

superficially, is not completed or

not conducted at all?

2

(0.7%)

16

(6%)

25

(9%)

239

(84%)




medication?

6

(2%)

27

(10%)

44

(17%)

188

(71%)




29

(11%)

42

(16%)

54

(21%)

135

(52%)

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Table 4: Results of logistic regression analysis with dichotomized double-check

appropriateness rating as outcome; model with cluster robust standard errors

Odds

ratio

95% CI P value

Double-check type ( to reference “A”)

B 0.184 0.107,0.317 <0.001

C 0.491 0.290,0.832 0.008

D 1.128 0.626,2.032 0.688

E 2.078 1.185,3.641 0.011


occasionally 0.211 0.126,0.354 <0.001

no 0.058 0.035,0.096 <0.001


Repeated single check 1.683 0.915,3.096 0.094

Two independently 1.597 0.936,2.725 0.086

Age, years 1.008 0.986,1.031 0.455

Female gender 3.183 1.363,7.432 0.007


25-40 hours 0.601 0.348,1.037 0.067

>40 hours 0.668 0.359,1.244 0.204


scanning

0.959 0.616,1.493 0.853

Head nurse 0.574 0.234,1.405 0.224



0.703 0.404,1.223 0.212


the past 12 months

0.775 0.470,1.278 0.318



R-squared 0.35


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FIGURES LEGENDS



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Fig 1

165x150mm (300 x 300 DPI)

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Fig 2

297x78mm (300 x 300 DPI)

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STROBE 2007 (v4) Statement—Checklist of items that should be included in reports of cross-sectional studies

Section/Topic Item

# Recommendation Reported on page #

Title and abstract 1 (a) Indicate the study’s design with a commonly used term in the title or the abstract See title page 1 and

abstract page 2

(b) Provide in the abstract an informative and balanced summary of what was done and what was found See objectives and

methods in abstract,

page 2

Introduction

Background/rationale 2 Explain the scientific background and rationale for the investigation being reported Pages 4-6

Objectives 3 State specific objectives, including any prespecified hypotheses Pages 5 and 6

Methods

Study design 4 Present key elements of study design early in the paper Pages 6 and 7

Setting 5 Describe the setting, locations, and relevant dates, including periods of recruitment, exposure, follow-up, and data

collection

Page 8

Participants

6

(a) Give the eligibility criteria, and the sources and methods of selection of participants Page 8

Variables 7 Clearly define all outcomes, exposures, predictors, potential confounders, and effect modifiers. Give diagnostic criteria, if

applicable

Pages 8 and 9

Data sources/

measurement

8* For each variable of interest, give sources of data and details of methods of assessment (measurement). Describe

comparability of assessment methods if there is more than one group

N/A

Bias 9 Describe any efforts to address potential sources of bias N/A

Study size 10 Explain how the study size was arrived at Page 8

Quantitative variables 11 Explain how quantitative variables were handled in the analyses. If applicable, describe which groupings were chosen and

why

Pages 8 and 9

Statistical methods 12 (a) Describe all statistical methods, including those used to control for confounding Page 8 and 9

(b) Describe any methods used to examine subgroups and interactions Page 8 and 9

(c) Explain how missing data were addressed Page 10

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(d) If applicable, describe analytical methods taking account of sampling strategy N/A

(e) Describe any sensitivity analyses N/A

Results

Participants 13* (a) Report numbers of individuals at each stage of study—eg numbers potentially eligible, examined for eligibility,

confirmed eligible, included in the study, completing follow-up, and analysed

Page 9

(b) Give reasons for non-participation at each stage N/A

(c) Consider use of a flow diagram N/A

Descriptive data 14* (a) Give characteristics of study participants (eg demographic, clinical, social) and information on exposures and potential

confounders

Page 9

(b) Indicate number of participants with missing data for each variable of interest Page 10

Outcome data 15* Report numbers of outcome events or summary measures Pages 8 and 9

Main results 16 (a) Give unadjusted estimates and, if applicable, confounder-adjusted estimates and their precision (eg, 95% confidence

interval). Make clear which confounders were adjusted for and why they were included

Page 22, page 11

(b) Report category boundaries when continuous variables were categorized Page 9

(c) If relevant, consider translating estimates of relative risk into absolute risk for a meaningful time period N/A

Other analyses 17 Report other analyses done—eg analyses of subgroups and interactions, and sensitivity analyses Pages 9-11

Discussion

Key results 18 Summarise key results with reference to study objectives Page 12

Limitations 19 Discuss limitations of the study, taking into account sources of potential bias or imprecision. Discuss both direction and

magnitude of any potential bias

Page 14

Interpretation 20 Give a cautious overall interpretation of results considering objectives, limitations, multiplicity of analyses, results from

similar studies, and other relevant evidence

Pages 11-14

Generalisability 21 Discuss the generalisability (external validity) of the study results Page 14

Other information

Funding 22 Give the source of funding and the role of the funders for the present study and, if applicable, for the original study on

which the present article is based

Page 15

*Give information separately for cases and controls in case-control studies and, if applicable, for exposed and unexposed groups in cohort and cross-sectional studies.

Note: An Explanation and Elaboration article discusses each checklist item and gives methodological background and published examples of transparent reporting. The STROBE

checklist is best used in conjunction with this article (freely available on the Web sites of PLoS Medicine at http://www.plosmedicine.org/, Annals of Internal Medicine at

http://www.annals.org/, and Epidemiology at http://www.epidem.com/). Information on the STROBE Initiative is available at www.strobe-statement.org.

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Medication double-checking procedures in clinical practice – a cross-sectional survey of oncology nurses’ experiences

Journal: BMJ Open

Manuscript ID bmjopen-2016-011394.R2


Date Submitted by the Author: 17-May-2016





Keywords:




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Original Research

Medication double-checking procedures in clinical practice – a cross-sectional survey of

oncology nurses’ experiences









Word count: 4837

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ABSTRACT

Background: Double-checking is widely recommended as an essential method to prevent

medication errors. However, prior research has shown that the concept of double-checking is

not clearly defined, and that little is known about actual practice in oncology, e.g., what kind

of checking procedures are applied.

Objective: To study the practice of different double-checking procedures in chemotherapy

administration and to explore nurses’ experiences e.g., how often they actually find errors

using a certain procedure. General evaluations regarding double-checking, e.g., frequency of

interruptions during and caused by a check, or what is regarded as its essential feature were

assessed.

Methods: In a cross-sectional survey, qualified nurses working in oncology departments of

three hospitals were asked to rate five different scenarios of double-checking procedures

regarding dimensions such as frequency of use in practice and appropriateness to prevent

medication errors; they were also asked general questions about double-checking.

Results: Overall, 274 nurses (70% response rate) participated in the survey. The procedure

of jointly double-checking (“Read-read back”) was most commonly used (69% of

respondents) and rated as very appropriate to prevent medication errors. Jointly checking

medication was seen as the essential characteristic of double-checking – more frequently

than “carrying out checks independently” (54% vs 24%). Most nurses (78%) found the

frequency of double-checking in their department appropriate. Being interrupted in one’s own

current activity for supporting a double-check was reported to occur frequently. Regression

analysis revealed a strong preference towards checks that are currently implemented at the

responders’ workplace.

Conclusion: Double-checking is well-regarded as a procedure to help prevent errors by

oncology nurses, with jointly checking being used most frequently. Our results show that the

notion of independent checking needs to be transferred more actively into clinical practice.

The high frequency of reported interruptions during and caused by double-checks is of

concern.

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in cancer care.







nature of the data.

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INTRODUCTION

Medication errors pose a serious threat to cancer patients (1-5). Walsh et al. reported that


error with more than half of all errors occurring during administration (6). Although not all





administration of drugs (7-11). Double-checking of medication is the safety intervention

frequently called for, especially to prevent administration errors. The Institute for Safe

Medication Practices (ISMP) recommends the implementation of the double-check, but

judiciously, and in a standardized process (12). The ISMP also points to the importance of

independence of checking procedures where the first professional does not communicate the

results to expect to the second professional. The UK National Patient Safety Agency

recommends health care organizations to “use double-checking systems such as an

independent check by another practitioner, and dose checking software in ‘Smart’ infusion

pumps and syringe drivers” (13). Double-checking (DC) can be defined as a procedure that

requires two qualified health professionals, usually nurses, checking the medication before

administration to the patient. DC is a redundant function based on the subjective theory that

human errors can be minimized by other individual’s compensatory behavior (14). The

strategy is borrowed from system engineering where redundancy is used to achieve safety

and reliability in technical systems. In broad terms, redundancy means that a system

component (e.g., mass storage) is duplicated and serves as a back-up in case of failure.

Redundancy as a design strategy for healthcare systems has been discussed by Tamuz and

Harrison in the context of high-reliability theory and normal accident theory (15). Despite the

proliferation of the procedure and its ad-hoc plausibility, there is a paucity of research into the

effectiveness of double-checking to either support or refute this practice (16). In this context,

it is important to note that double-checking medication administrations is a time consuming

and thus resource intensive process (17-19).


on what constitutes a double-check and how it should be performed. In practice, various

forms of DC procedures are implemented including, for example, a single person conducting

the same check twice; a second person verifying the check of the first professional (do-and-

show check); a single person checking against some form of computerized support (e.g.,

calculations performed by an infusion pump); two professionals checking independently from

each other, and sequentially or together (e.g., read-read back). Due to such variability in DC

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processes, it is not surprising that there are reports about confusion and misconceptions

among healthcare professionals (20;21). In a recent qualitative study in Canada, DC was

inconsistently conceptualized among healthcare professionals with a variety of ambiguous

but “taken as understood” meanings attached to it (21). Nurses at many departments today

perform countless single and double drug verifications, often under inadequate working

conditions (e.g., insufficient light, space, noise) and without any compensation for the time

needed to perform these checks. Often these checks are done superficially (22) and “true




lack of standardization (22;23). Furthermore, DC itself can negatively impact safety by

causing a considerable number of additional interruptions in workflow. Finally, diffusion of

responsibility can lead to a false sense of safety through reliance on the following check (24)

and thus increase risk. In qualitative studies, nurses indicated that DC reduced the perceived

responsibility of individuals because they trust in the second checking person to find potential

mistakes – an effect, which is often called “social loafing” (20;25).

In oncology, DC is frequently recommended and claimed as a “state of the art” procedure

(26;27). The American Society of Clinical Oncology (ASCO) and the Oncology Nursing

Society (ONS) standards for the administration of chemotherapy require that before

chemotherapy administration, at least two practitioners a) verify patient identification using at

least two identifiers; b) confirm with the patient the planned treatment, drug route, and

symptom management; c) verify the accuracy of drug name, dose, volume, rate of and route

of administration, expiration dates/times and appearance and physical integrity of the drugs;

d) sign to indicate verification was done [16]. The Swiss nursing standards on chemotherapy

administration are not binding and state that, depending on the institutional policy, a double-

check of the drug and the dose should be conducted during preparation and administration

(28). There is, however, neither a definition or an explanation of a robust checking procedure

given in the document nor recommendations proposed on how DC should exactly be

performed.

Despite its wide diffusion, very little is known about DC practices in cancer care. This study

addresses this gap using a cross-sectional survey among oncology nurses. The main aim of

our study was to describe practice patterns (types, frequencies and independence of checks

performed) and oncology nurses’ experiences with the double-check in chemotherapy

administration.

Our primary research question was to assess which specific DC routines are implemented

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and what the experiences with them are. We examined what constitutes a ‘good double-

check’ for cancer nurses, how frequently procedures are violated, which barriers nurses

perceive in conducting DC in practice, and whether they would prefer an expansion or a

reduction of DC procedures.

Our secondary research question was to investigate nurses’ judgments about the

appropriateness of the various different DC procedures in discovering medication errors and

the factors affecting their evaluations. We hypothesized that nurses have clear judgments on

the value of different DC routines based on their prior experiences and their professional

expertise. Understanding nurses’ assessments of suitability of DC procedures is crucial for

implementing any changes to current DC practices and for developing a consistent

conceptualization of DC.

A further secondary research question was to determine if there were differences in DC

practices between inpatient and outpatient care. As clinical processes and working

conditions (e.g., patient flow and throughput, staffing, etc.) often differ considerably between

wards and ambulatory infusion units we assumed that this may also impact how double-

checks are performed and perceived. Knowledge about these differences would be useful for

designing DC procedures and policies that are adapted to the specific setting and context.

METHODS

Sample





paid envelope and a chocolate bar. Return of the survey was considered as implied informed

consent. The study was deemed exempt by the Cantonal ethics committee (KEK ZH Nr. 34-

2015) on the basis of the Swiss legislation (Human Research Act, HRA). Our study does not

involve interventions, no health-related data or biological material are being analyzed, the

data were completely anonymized and approached individuals could easily refuse

participation by not returning the survey.

Survey

Development


experts and clinical staff, and initial field observations. The main challenge in developing the

survey was the inconsistent, vague and variable concepts held by nurse clinicians and the

various procedures implemented in practice. It became obvious that simply asking details

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about “the double-check” would result in non-interpretable data due to non-standardized use

of the term. Therefore, we assessed which checking procedures are performed in practice

during initial field observations. One author visited all participating units and observed DC

practices to gain an understanding of the different forms of DC procedures implemented. In

informal conversations during and after observation, nurses were asked about the

procedures in a non-judgmental manner until the core steps, their sequence, the actions and

interactions between staff were clear for each scenario. The initial observations also gave

insights into common rules embedded in checking procedures (which are not necessarily

written down anywhere). For example, medications should be administered by a nurse

involved in the DC and not by a third person, and double-checks should not be done in series

for the medications of several patients. Finally, the field observations were also useful to

collect information about the environmental conditions under which DC is performed (e.g.,

rooms, light, noise). Based on the observations, we developed a) a set of scenarios

describing certain procedures and b) survey questions that were asked for every kind of

scenario in order to be able to compare the scenarios.

Six experts from nursing, oncology, clinical pharmacy, and hospital risk management gave

feedback on a survey draft. The survey was pretested for clarity and wording in a sample of

n=39 HCW from two hospitals not participating in the main study. Only minor adjustments

were made.

Survey instrument

The survey consisted of two main sections: In the first section (reported herein), we used

scenarios describing DC procedures implemented in clinical practice and asked responders

to rate these scenarios regarding various aspects. This allowed us to assess practice

patterns, experiences with different DC procedures and clinicians’ judgments of the

effectiveness of DC procedures in discovering medication errors. We used these scenarios

of different DC procedures to obtain detailed evaluations and to avoid the loosely and

inconsistently defined “umbrella concept” of DC. In this section, we also asked some general

items related to DC, e.g., regarding unit policy or perception of essential elements of DC. The

second survey part (not reported herein) assessed norms and beliefs in DC effectiveness for

medication safety.

DC scenarios and related survey items

In the field observations, we identified five different core DC procedures implemented in

practice. For each of them, we developed a brief description and an illustration of the main

steps (scenarios A-E, see figures 1 and 2). Each participant responded to all scenarios and

was asked the same set of questions for each scenario:

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all”);



3) item 3: How many of such double-checks they personally conduct on an

average working day, including cytostatics, potassium, antiemetics (none/1-5

/6-10 /more than 10);


during a double-check of this type (daily or several times daily/weekly or

several times weekly/monthly or several times monthly/few times per

year/never);







Generalized items


to indicate the existence of guidelines for DC at their unit; essential elements of a good

double-check; number of double-checks at their unit; the frequency of violations of DC

procedures (see table 3 for details); frequency of interruptions caused by DC and conditions

interfering with performing a good double-check; practice and preferences towards the DC of

premedications (drugs given prior to chemotherapy to prevent side effects of treatment, e.g.,

antiemetic drugs and steroids); and recent experience of severe medication errors. Finally,

respondents completed a few socio-demographic and work-related items.

Analysis

Survey responses were descriptively analyzed. Due to item-level missing data, the sample

size varies slightly per item. Chi-square tests were conducted to identify group differences

between wards and ambulatory infusion units. In order to test for differences in nurses’

appropriateness ratings (item 1 listed above) between DC scenarios, ANOVA was used.

To answer our secondary research question, i.e., determine predictors for the

appropriateness ratings (item 1 listed above), logistic regression analysis was conducted. As

each responder evaluated five scenarios, the unit of analysis in this regression model was

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the judgment provided in response to the scenarios, and not the individual respondent. The

sample size for this analysis is thus n=number of responders x number of rated scenarios.

The dependent variable (appropriateness rating, item 1 listed above) was dichotomized with

values 1-4=not appropriate and values 5-7=appropriate. Type of DC procedure evaluated

(scenarios A-E), current implementation of this DC procedure at the unit, and perceived

essential element of a good double-check were included as predictors (independent

variables). With this analysis, we assess the impact of nurses’ current DC practices at their

workplace on their ratings of appropriateness of the distinct DC procedures. In other words,

we correct DC appropriateness ratings for a bias towards “current practice”. Personal and

work-related characteristics were included to adjust the appropriateness ratings. We used

cluster robust standard errors to relax the assumption of independence of observations

within individuals. All tests were two-sided and a p-value <0.05 was considered significant.

RESULTS



working on wards for at least 25 hours per week in direct patient care. The majority of nurses

(80%) reported that there were internal guidelines explaining which checks were required for

which medications and that they knew them well. Knowing that such guidelines existed but

not knowing their contents well was reported by 11%. The remainder was not aware of

guidelines for their unit. Overall, 68 responders (25%) reported that one or more serious

medication errors had taken place in their unit during the past 12 months. Of those, the

majority (68%) believed that the last serious error could have been prevented with a

thorough double-check.

Practice patterns and experiences with DC procedures

Table 2 reports practice patterns and experiences with the different DC scenarios. “Read-





significant higher frequencies of double-checks. Summarized across the different DC

procedures, 48% of all frequency ratings provided by ambulatory nurses indicate

performance of > 5 checks per day vs. 15% of these ratings reported by nurses on ward

(p<0.001). The reported frequency with which DC procedures detected errors and

inconsistencies varied considerably. Approximately a fifth of nurses practicing procedure B

(repetitive single check) and C (repetitive single check of order, calculations, and drugs for

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preparation) reported that these checks detected inconsistencies at least several times a

week. Contrary, the more widely implemented DC procedures were reported to detect

inconsistencies with much lower frequency. Only between 37% (scenario C) and 51%

(scenario E) of participants reported that commonly the second nurse did not know the

results of her preceding colleague when she repeated a counting or calculating procedure

(truly independent check). Across all presented DC procedures, the majority of responders

would not eliminate the procedure from their routines (range: 73%-94%).

Characteristics of the double-check and violations


double-check: 'two persons check the medication together' was selected as main feature by

54%; 'two persons make the same checks successively' was selected by 22% of responders

and 24% answered that 'one person independently repeats a process (e.g., counting) without

knowing the results of her preceding colleague' was the crucial characteristic of a good

double-check. There were no significant differences in evaluations of the main feature of a

good double-check between nurses working on wards or at ambulatory units. Nurses

reported different types of violations of medication safety rules related to DC with varying

levels of frequency (table 3): Performing the double-check for medications of several patients

in series – without a break and without completing the drug administration before starting the

double-check for the next patient – was the most commonly reported deviation from safe DC

rules. Of responders, 36% reported any of the three types of violations to happen at least

several times per week at their unit (ambulatory infusion unit: 46%; ward=32%, p=0.074).

Number of double-checks at unit

When asked to consider the number of double-checks at their unit, most surveyed nurses

regarded the scheduled number of double-checks in their unit as good and appropriate

(78%). Additional double-checks were favored by 17%. Only a small minority said there

should be fewer double-checks (5%). A preference towards additional double-checks was

significantly more frequent among responders working on wards compared to ambulatory

infusion units (21% vs. 2%, p=0.005). Half of the respondents (49%) reported that

premedications were not double-checked at all at their unit (19% routinely and 28%

occasionally). Responders were nearly equally split in their preferences for or against the DC

of premedications: 55% said they would favor and 45% would opt against a routine DC of all

premedications, were they free to decide for their unit. Those who already routinely

performed double-checks on premedications were much more likely to support this

procedure (90%) as compared to those that checked them only occasionally or not at all

(47%, OR=10.43, p<0.001).

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Interruptions and barriers for DC performance


colleague doing a double-check: 1-5 interruptions of their current activity per day were

reported by 39%; a substantial fraction (20%) experienced more than 5 interruptions per day.

Nurses working at ambulatory infusion units self-reported significantly more interruptions

than nurses working on wards (40% vs. 16% reporting more than five interruptions per day,

p=0.001). Nearly all respondents (96%) reported at least one factor which frequently

interferes with performing good DC (multiple answers possible): 78% felt disturbed by hurry

and hectic at the unit, 78% by interruptions and distractions, 58% by noise and poor

illumination in the medication room, 53% by problems to find a colleague for DC, 29% by

overcrowded rooms and 25% by their own fatigue.

Appropriateness of DC procedures and its predictors



routines. The differences in the appropriateness ratings between DC procedures were

considerable (ANOVA F=76.6, p<0.0001). The ratings were highest for scenarios A


C (mean=4.9, CI 4.8-5.2), and B (mean=3.9, CI 3.7- 4.2). Results of the logistic regression

analysis confirm that the appropriateness of the five different DC procedures was judged

differently, even after adjusting for other variables (table 4). DC procedures B and C were

perceived as significantly less useful in preventing medication errors compared to

procedures A and E. DC procedures which were implemented at the responder’s work

environment and thus currently personally experienced scored systematically higher on the

appropriateness rating, even after adjusting for the type of check and other variables:

Procedures nurses were currently using at their unit were more than 17-times more likely to

be judged appropriate compared to procedures outside their scope of current experience.

The difference between the categories “not practiced” and “occasionally practiced” explained,

on average, a one-point difference on the response scale. Finally, female gender was the

only personal and work-related variable affecting the perceived benefit of DC procedures for

preventing medication errors. Working on ward or at the ambulatory units did not affect

appropriateness ratings.

DISCUSSION

To the authors‘ knowledge this is the first analysis of nurses‘ experiences with and

evaluations of different procedures of double-checking of medication in cancer care. We

surveyed experienced oncology nurses from three large hospitals including wards and

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ambulatory infusion units. The response rate was satisfactory.

Positive experiences and support for DC

Nurses in our study had positive attitudes towards DC, expressed in the high

appropriateness ratings of all checking procedures and the fact that more than half of the

respondents would also prefer to extend the double-check to premedications. The five

described DC procedures were regarded to be of different value with the joint “read-read

back” check involving two nurses being rated the most appropriate. The strong, general

support for DC is connected to the personal experiences reported by the nurses: Depending

on the DC scenario presented, between 45% and 25% of participants indicated that at least

several errors per month had been detected using this method. Thus, in their everyday work

life, nurses commonly make the experience that inconsistencies are detected with double-

checking. Contrary, inconsistencies not found during checking and the extent of errors which

remain invisible but could be found with other checking procedures are not personally

experienced. Thus, every “hit” sends a positive feedback and reinforces the positive attitude

towards DC. Our finding that two thirds of nurses who experienced a recent medication error

believed that this error could have been prevented with thorough DC suggests that the

selective confirmation of DC may cause a generalisation of its perceived effectiveness.

Preferences towards current practice

While the variance in appropriateness ratings confirms that participants sensitively

responded to the scenario descriptions and adjusted their judgment accordingly our results

also emphasize a “bias towards the known” with regard to currently practiced DC

procedures. Whether a certain check was implemented at the unit was a significant

independent predictor for a high appropriateness rating. This status quo bias is also

expressed in various other survey items: For example, the vast majority of responders

indicated that they would not eliminate or change the frequency of specific checks and

regarded the extent of checks at their unit as “just right”. Nurses who currently routinely

perform double-checks on premedications strongly supported this procedure whereas those

who currently do not double-check were reserved about introducing this practice. Our results

lend support to an Australian study which reported a reluctance to de-implementation of DC

among nurses. In this study nurses held strong views against single checking before

practice was changed from double to single checking (29). This preference against change

demonstrates the virtual “inviolability” of the double-check notwithstanding the increasing

evidence questioning the effectiveness of currently implemented DC procedures.

Independence of checks

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of what constitutes a double-check, the importance of independence of checks and how it

can be achieved (20;21). Only a quarter regarded the independence of checks as the

essential feature of DC whereas twice as much selected “doing the checks together”. In




prevalent misunderstanding of the rationale behind double-checking procedures. One basic

prerequisite of the redundancy principle to be successful is the independence between

redundant “units” (30). In technical systems this requirement is usually satisfied because

non-living objects (e.g., computers) which serve as backup for other non-living objects are

unaware of each other. Their performance is unaffected by the presence or absence of the

redundant unit. In contrast, this principle is typically violated in social systems. Human

subjects are aware that their coworkers will conduct redundant checks. Independence within

the specific check itself can be more or less simulated (e.g., by not sharing information as

recommended in DC guidelines)(12). Yet, even simply knowing that a second check will be

conducted may negatively affect motivation and result in the tendency to make less effort.

The violation of independence can result in greater diffusion of responsibility and thus

decreased system safety (14). This has been confirmed in qualitative studies, in which

nurses indicated that DC would reduce the perceived responsibility of individuals because

others would pick up potential mistakes (20;25). Oncology nurses in our survey judged the

read-read-back procedure, a routine which relies on the presence and literally “dialogue” of

two nurses, as most appropriate. These professionals are persistently confronted with

administering high-risk drugs to vulnerable patients and the genuine function of DC here may

indeed be to share responsibility for safe drug administration. Furthermore, the identified

misconception of the independence principle and its importance in combination with the

finding that many nurses felt disturbed by environmental factors means that while doing their

checks together, nurses are subject to the same environmental impacts, such as insufficient

light or noise or interruptions. Consequently, we advocate to critically discussing what true

independence in double-checking means and how it can be achieved in clinical practice. Our

results also support the proposition to define what is meant by a double-check more

precisely (21).

Potential hazards connected to DC

Recent analyses of incidents revealed how many collaborative cross-checks failed and did

not prevent severe incidents (31). Based on our findings, we would like to raise awareness

about potential hazards that may be connected to DC.

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First, our results highlight the interplay between DC and interruptions in workflow: Nurses

reported frequent interruptions caused by DC, in particular at the ambulatory infusion units,

and often felt disturbed by interruptions during DC. Given the evidence that interruptions in

medication-related tasks are strongly associated with errors, this is alarming (32;33). Based

on direct observation of medication administration, Trbovich et al. reported that nurses in

ambulatory infusion units were interrupted 22% of their time and frequently interrupted during

safety-critical stages (34). Our results confirm that medication administration at ambulatory

infusion units may be particularly affected by frequent interruptions. Prakash et al. recently

investigated the effects of interruptions during chemotherapy verification and administration

on the frequency of errors (35). In this study, nurses made significantly more errors in

verification of medication volumes in syringes and infusion pumps when interrupted. Taking

these studies into account, our results indicate that without reorganizing DC routines in

clinical practice, the procedure may in fact increase the risk for error.

Second, the strong, general support for DC we observed co-exists with frequent violations of

important DC rules. A third of responders were aware of at least weekly non-adherence to

safety rules at their unit, such as double-checking medications for different patients in series

without break. Such violations of safety rules undermine the value of DC procedures by

limiting its potential effectiveness and promoting a false sense of safety.

Third, a considerable fraction of nurses (11%) in our study reported that they did not know

the contents of medication administration guidelines at their unit well, and nearly 10% were

unaware whether such guidelines existed. This finding is per se concerning and confirms that

even local medical guidelines and safety standards are often not well disseminated and

known in practice. It may also suggest that the guidelines in place are not perceived as being

usable or helpful for practice. For example, the local guidelines of the participating units we

consulted mention DC, but do not provide any details on how checks should be done. Taken

together, nurses may receive confirmation and safeguarding during chemotherapy

verification from doing checks together and sharing responsibility rather than from complying

with (vague) guidelines.

LIMITATIONS








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CONCLUSIONS

Generally, the survey showed that DC is a procedure well-supported by nurses working in

oncology which, in their experience, helps to detect errors. They used joint DC frequently,

preferred this method over others and rated it appropriate to prevent medication errors.

These findings show that clinicians’ perspectives are not matching current recommendations

claiming that checks need to be carried out independently to increase safety. Thus,

knowledge about the importance of independence in DC needs to be transferred more

actively into clinical practice, so that healthcare professionals implementing and using DC

procedures can adopt their procedures accordingly.The high frequency of reported

interruptions during and caused by DC is of great concern. Existing ideas to reduce

interruptions during checking such as quiet zones need to be tested in future research.

ACKNOWLEDGMENTS

We thank all nurses who participated in the survey. The support of the clinical experts in

providing feedback to the survey and especially of Anna Götz (nursing expert) in survey

design and field testing is highly appreciated.


DS, YP and KT contributed to design of the study and the survey instrument. DS analyzed


provided important intellectual content. All authors approved the manuscript.

COMPETING INTERESTS


FUNDING



Hanela-Stiftung.



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